MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.5MM X 30MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EZAS45300

Device Problem Premature Indicator Activation (3011)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2020

Event Type  malfunction  

Manufacturer Narrative

At stryker model farm road, the edhr (electronic device history record) for each lot is created and maintained in mes (manufacturing execution system).Automated controls within the mes system ensure that all product is manufactured in accordance to the dmr (device master record).The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.Information available indicated that the device was confirmed to be in good condition prior to use.Based on the information currently available, the exact cause for the reported event cannot be determined.The reported complaint could not be confirmed and it could not be definitively determined if the device failed to meet specifications because the product was not returned.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned.Should any information become available in the future that could impact the current assessment decision, the complaint will be reopened and updated accordingly.

Event Description

It was reported that during coil embolization procedure, the stent (subject device) could not be confirmed on x-ray while advancing in the catheter.When the catheter was removed, it was found that the stent had prematurely deployed during procedure.A catheter was used to recover the subject stent and the procedure was completed successfully.There were no clinical consequences reported to the patient.

• Brand Name: NEUROFORM ATLAS 4.5MM X 30MM NO TIP - CE
• Type of Device: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 9998697
• MDR Text Key: 189501550
• Report Number: 3008881809-2020-00120
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: JP
• PMA/PMN Number: P180031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: M003EZAS45300
• Device Lot Number: 19292211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1